Systems and methods for characterizing a patient's propensity for a neurological event and for communicating with a pharmacological agent dispenser

Abstract

The present invention provides systems and methods for managing intake of a pharmacological agent. In one method of the present invention, the systems and methods are for controlling intake of an anti-epileptic drug. In such embodiments, one or more signals from a patient are processed to predict an onset of a seizure. Upon the prediction of the seizure, the patient is allowed to access the pharmacological agent in a pharmacological agent dispenser.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] The present invention claims benefit to U.S. patent application Ser. No. ______, filed Dec. 28, 2005, entitled “Methods and Systems for Recommending an Appropriate Action to a Patient for Managing Epilepsy and Other Neurological Disorders,” (BNC Docket No. 2.00US; WSGR Docket No. 31685-713.201) and U.S. patent application Ser. No. ______, filed Dec. 28, 2005, entitled “Methods and Systems for Recommending a Pharmacological Treatment to a Patient for Managing Epilepsy and Other Neurological Disorders” (BNC Docket No. 2.01US; WSGR Docket No. 31685-713.202), both to Leyde et al., the complete disclosures of which are incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] The present invention relates generally to monitoring a patient's condition and controlling administration of a pharmacological agent. More specifically, the present invention is directed to characterizing a patient's propensity for a future seizure and facili...

AI Technical Summary

Benefits of technology

[0010] The present invention addresses the problem of chemical abuse of AEDs by providing a way to selectively limit the access to and administration of the AEDs. The systems and methods of the present invention are able to characterize the patient's propensity or likelihood of a future seizure. Upon determination of an increased propensity or likelihood of the future seizure, the present invention facilitates allows the patient to access the AED. In preferred embodiments, the patient is only allowed to access a dosage of the AED that is needed to prevent the seizure. The ability of the present invention to deliver an AED at substantially the lowest effective dose and at or near the time when the patient has an elevated propensity would minimize the exposure of the patient to side effects, maximize the benefit of the AED and help limit the potential chemical abuse of the AED.

[0011] As used herein, the term “anti-epileptic drug” or “AED” generally encompasses pharmacological agents that have been determined to reduce the frequency or propensity for a seizure. There are many drug classes that comprise the set of antiepileptic drugs (AEDs) that may be used by the present invention, and many different mechanisms of action are represented. For example, some medications are believed to increase the seizure threshold, thereby making the brain less likely to initiate a seizure. Other medications retard the spread of neural bursting activity and tend to prevent the propagation or spread of seizure activity. Some AEDs, such as the Benzodiazepines, act via the GABA receptor and globally suppress neural activity. However, other AEDs may act by modulating a neuronal calcium channel, a neuronal potassium channel, a neuronal NMDA channel, a neuronal AMPA channel, a neuronal metabotropic type channel, a neuronal sodium channel, and / or a neuronal kainite channel, and all are encompassed by the present invention.

[0017] In preferred embodiments, the drug dispenser is in one-way or two-way communication with at least one component of the system of the present invention. The drug dispenser may be in communication with a device that is external to the patient's body and / or a device that is implanted in the patient's body. The communication link between the dispenser and other components of the system may be used to control the administration of the AED to the patient. In preferred embodiments, when it is determined that the patient is at an elevated propensity for a seizure, the communication link is used to allow the patient to access to the dispenser or enable a patient or caregiver to dispense the drug (e.g., unlock the dispenser). The communication link may also be used to prevent access to the dispenser (e.g., lock the dispenser), control the rate of access, control the amount time that the drug is accessible by the patient, control the amount of drug that is administered, and the like.

[0018] Controlling access to the AED has a number of advantages. First, it provides a way of reducing, and preferably preventing, abuse of the AEDs by allowing the patient to access the AED only when it is determined that the patient has an elevated propensity for a seizure. Second, it allows administration of only the amount of AED needed to prevent or otherwise manage the predicted future seizure. Such titration may be done automatically by the system or the patient may be instructed to titrate.

[0029] The classifier is configured to combine the results obtained from the feature extractors and other signals into an overall answer or result, which classifies the patient's state and characterizes the patient's propensity for the future seizure. The classifier may provide a simple characterization that the patient is at an increased risk of a seizure, e.g., the patient's neural state has changed from a normal (e.g., inter-ictal state) to a state that is consistent with a predetermined state such as a “an elevated propensity for seizure state” or “pre-ictal” state (e.g., a state that precedes an “ictal” or seizure state). Alternatively, the classifier may provide a graded answer that that would allow for estimation of a prediction interval (e.g., 30 seconds or more, 1 minute or more, 2 minute or more, 5 minutes or more 10 minutes or more, 30 minutes or more, 60 minutes or more, or the like), characterization of a graded response that is a function of the graded answer, or the like.

[0031] While the remaining discussion focuses characterizing a patient's neural state to predict an onset of future seizures and providing a communication link with an AED dispenser, it should be appreciated that the present invention may be used to monitor other neurological and non-neurological conditions and facilitate the administration of other therapies besides pharmacological agents. For example, the present invention may monitor the cardiac system and be used to titrate a patient's heart medication, monitor glucose levels and control administration of insulin, or monitor other neurological conditions (e.g., depression, Parkinson's disease, or the like) and provide for controlled administration of the related drugs. Advantageously, by predicting the occurrence of some event and facilitating controlled administration of a pharmacological agent, the present invention is able to control the disorder, while reducing the side effects caused by the pharmaceutical agent. INCORPORATION BY REFERENCE

Problems solved by technology

A seizure typically manifests as sudden, involuntary, disruptive, and often destructive sensory, motor, and cognitive phenomena.

Seizures are frequently associated with physical harm to the body (e.g., tongue biting, limb breakage, and burns), a complete loss of consciousness, and incontinence.

A single seizure most often does not cause significant morbidity or mortality, but severe or recurring seizures (epilepsy) results in major medical, social, and economic consequences.

Epilepsy is most often diagnosed in children and young adults, making the long-term medical and societal burden severe for this population of patients.

People with uncontrolled epilepsy are often significantly limited in their ability to work in many industries and cannot legally drive an automobile.

This continuous seizure activity may lead to permanent brain damage, and can be lethal if untreated.

The anticonvulsant and antiepileptic medications do not actually correct the underlying conditions that cause seizures.

Some of the fast acting AEDs are primarily used as sedatives, and their desired therapeutic effects are often accompanied by the undesired side effect of sedation.

While chronic usage of AEDs has proven to be relatively effective for a majority of patients suffering from epilepsy, the persistent side effects can cause a significant impairment to a patient's quality of life.

Furthermore, about 30% of epileptic patients are refractory (e.g., non-responsive) to the conventional chronic AED regimens.

Because of the severe side effects caused by the chronic administration of high dosages of AEDs, patient compliance with the chronic AED regimen has proven to be a difficult problem to overcome.

Consequently, many patients are still prone to seizures due to the noncompliance with their chronic AED regimen.

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